Expired Study
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Bethesda, Maryland 20892


This is a phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy in metastatic breast cancer patients.

Study summary:

Phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy.


Patients with Stage IV (metastatic) breast cancer are eligible who have a histologically-proven diagnosis. Measurable disease is not a prerequisite. Patients with Stage III disease or Stage ll with 7 or more nodes positive are eligible. Patients who have had prior adjuvant chemotherapy and/or hormonal therapy are eligible providing the regimen did not include adriamycin. Patients who have had prior radiation therapy may be eligible providing there was not extensive radiation to the cardiac area or to greater than 20% of the bone marrow. Patients who have received greater than 360mg/m2 of adriamycin as adjuvant therapy are ineligible. Patient must be previously untreated with chemotherapy for metastatic disease. There must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years. Performance status (Karnofsky scale) must be greater than 70; ECOG 0-2. Absolute granulocyte count greater than 1500/mm3 and platelet count greater than 100,000/mm3. Liver function tests (SCOT, Alk, Phosph., and T. Bili) should be less than 1.5 time the upper limits of normal. Serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min unless these abnormalities are due to tumor involvement. The patient must be able to give an informed consent, and to return to NCI for treatment and adequate follow-up for the period the protocol requires. No pregnant patients may be entered on this study; all patients should be informed about the need for contraception. Patients must be greater than or equal to 18 years of age. No patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol. No patients with a history of cardiac disease must have a normal ejection fraction by MUGA Scan and have no angina. Patients who have received prior adriamycin must have a LVEF greater than 45%. No history of CNS metastasis, or known seizure disorder. No allergy to any study medication. No pregnant or lactacting women. No patients requiring ongoing therapy for asthma. No patients with bleeding disorders.

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Phase I Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Plus GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) Plus Dose Escal

Official Title:

Phase I Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Plus GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) Plus Dose Escalation of IL-3 (Interleukin-3) in Metastatic Breast Cancer

Overall Status:


Study Phase:

Phase 1



Minimum Age:


Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Endpoint Classification: Safety Study, Primary Pu

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Study Dates

Start Date:May 1991
Completion Date:February 2001
Verification Date:April 2000
Last Changed Date:March 3, 2008
First Received Date:November 3, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Antman K, Gale RP. Advanced breast cancer: high-dose chemotherapy and bone marrow autotransplants. Ann Intern Med. 1988 Apr;108(4):570-4. Review.
Reference Type:Reference
Citation:Clark SC, Kamen R. The human hematopoietic colony-stimulating factors. Science. 1987 Jun 5;236(4806):1229-37. Review.
Reference Type:Reference
Citation:Metcalf D, Begley CG, Johnson GR, Nicola NA, Vadas MA, Lopez AF, Williamson DJ, Wong GG, Clark SC, Wang EA. Biologic properties in vitro of a recombinant human granulocyte-macrophage colony-stimulating factor. Blood. 1986 Jan;67(1):37-45.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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